UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044716
Receipt number R000051071
Scientific Title A study to evaluate the effect of dentist intervention on prognosis in patients with aspiration pneumonia.
Date of disclosure of the study information 2021/06/30
Last modified on 2024/04/05 11:30:07

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Basic information

Public title

A study to evaluate the effect of dentist intervention on prognosis in patients with aspiration pneumonia.

Acronym

Study on the prognosis of aspiration pneumonia

Scientific Title

A study to evaluate the effect of dentist intervention on prognosis in patients with aspiration pneumonia.

Scientific Title:Acronym

Study on the prognosis of aspiration pneumonia

Region

Japan


Condition

Condition

aspiration pneumonia

Classification by specialty

Medicine in general Geriatrics Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the prognosis of aspiration pneumonia with dentist intervention.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Evaluation of recurrence rate of aspiration pneumonia by dentist intervention

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Historical

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Maneuver

Interventions/Control_1

Intervention Group: Oral care by a dentist. Once a week for a total of one month
Control Group: Oral care by nurses

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Patients who were admitted to Juntendo Koto Geriatric Medical Center and met the diagnostic criteria for aspiration pneumonia.
The criteria for aspiration pneumonia were fulfilled both 1)-3).
1) Radiological findings compatible with aspiration pneumonia on chest x-ray or CT.
2) Witnessing of aspiration by family members, caregivers, medical staff, or others, or factors suggestive of aspiration.
3) Acute respiratory symptoms suggestive of pneumonia (cough, sputum, fever, dyspnea).

Key exclusion criteria

Exclusion criteria
(1) Patients admitted with aspiration pneumonia who do not meet the above diagnostic criteria
(2) Patients diagnosed with cancer, tuberculosis, or viral pneumonia
(3) Patients who were readmitted to the hospital, the data from the first hospitalization will be used to avoid duplication.
(4) Other patients who are judged by the principal investigator to be inappropriate as research subjects.

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Miyagami
Middle name
Last name Taiju

Organization

Juntendo University

Division name

General medicine department

Zip code

113-8431

Address

Tokyo-to Bunkyo-ku Hongo 3-1-3

TEL

0338133111

Email

tmiyaga@juntendo.ac.jp


Public contact

Name of contact person

1st name Miyagami
Middle name
Last name Taiju

Organization

Juntendo University

Division name

General medicine department

Zip code

113-8431

Address

Tokyo-to Bunkyo-ku Hongo 3-1-3

TEL

0338133111

Homepage URL


Email

tmiyaga@juntendo.ac.jp


Sponsor or person

Institute

Juntendo University

Institute

Department

Personal name



Funding Source

Organization

N/A

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Juntendo University

Address

Tokyo-to Koto-ku Shinsuna 3-3-20

Tel

0356323111

Email

kubota_kei@juntendo.gmc.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2021 Year 06 Month 30 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

185

Results


Results date posted


Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2021 Year 04 Month 01 Day

Date of IRB

2021 Year 02 Month 02 Day

Anticipated trial start date

2021 Year 04 Month 01 Day

Last follow-up date

2022 Year 09 Month 30 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2021 Year 06 Month 30 Day

Last modified on

2024 Year 04 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051071